Actively Recruiting
ARTEMIS-102: Phase Ib Study of HS-20093 Combination Therapy for Safety, Tolerability, Pharmacokinetics, and Efficacy in Advanced Metastatic Colorectal Cancer
Led by Hansoh BioMedical R&D Company · Updated on 2025-02-13
560
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying HS-20093, a fully humanized antibody-drug conjugate that targets B7-H3, a protein commonly found on solid tumor cells. This phase 1b, open-label study focuses on patients with advanced metastatic colorectal cancer to evaluate the safety, tolerability, pharmacokinetics, and efficacy of HS-20093 when combined with other anti-cancer drugs. The study involves five different combination treatments of HS-20093 with medications such as Bevacizumab, 5-fluorouracil (5-FU), Leucovorin, Capecitabine, and Oxaliplatin. All these drugs are given either by intravenous infusion or orally, depending on the medication. The study includes a dose-escalation phase for patients who have already tried standard treatments without success, and a dose-expansion phase for those who have not received prior treatment for advanced metastatic colorectal cancer. Participants will be monitored closely for side effects during treatment and for 90 days afterward. They may continue therapy if it is well tolerated and clinical benefit is observed. Researchers will assess the maximum tolerated dose, adverse events, tumor response, disease control, survival times, and drug levels in the blood for up to 24 months. The total duration and specific follow-up visits will vary based on individual treatment courses.
CONDITIONS
Brief Title
ARTEMIS-102: HS-20093 Combinations in Patients with Advanced Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at screening
- Histologically or cytologically confirmed locally advanced or metastatic colorectal cancer
- For dose escalation: progressed on or intolerant to standard therapies
- For dose expansion: no prior treatment for advanced/metastatic colorectal cancer
- At least one measurable lesion by RECIST 1.1
- ECOG Performance Status of 0 or 1
- Life expectancy of at least 12 weeks
- Use of adequate contraceptive measures during the study
- Female participants must not be pregnant and have non-childbearing potential
- Signed and dated informed consent form
You will not qualify if you...
- Previous or current treatment with B7-H3 targeted therapy or ADCs with topoisomerase I inhibitors
- Cytotoxic chemotherapy, investigational agents, or targeted therapy within 14 days before first HS-20093 dose
- Macromolecule anti-tumor therapy or other anticancer drugs within 28 days before first HS-20093 dose
- Limited field radiotherapy within 2 weeks, large-scale or extensive bone marrow irradiation within 4 weeks before first HS-20093 dose
- Pleural or peritoneal effusion requiring clinical intervention or pericardial effusion
- Major surgery within 4 weeks of first HS-20093 dose
- Spinal cord compression or brain metastases
- Treatment with strong CYP3A4 inhibitors/inducers or sensitive substrates within 7 days before or during study
- Use of drugs prolonging QT interval or causing torsade de pointe during study
- Unresolved toxicities greater than Grade 2 except stable hypothyroidism, alopecia, or neurotoxicity
- History of other primary cancers
- Inadequate bone marrow or organ function
- Evidence of cardiovascular risk or severe uncontrolled cardiovascular disease
- Diabetes ketoacidosis or severe hyperglycemia within 6 months
- Severe or poorly controlled hypertension
- Significant bleeding symptoms within 1 month
- Serious thrombosis within 3 months
- Severe infections within 4 weeks
- Long-term steroid treatment or immunodeficiency diseases
- Active infections such as hepatitis B or C, tuberculosis, syphilis, or HIV
- Severe liver diseases or cirrhosis
- Moderate or severe lung diseases affecting study
- Serious neurological or mental disorders
- Pregnancy or breastfeeding
- Severe hypersensitivity or allergy to study drugs
- Noncompliance or conditions affecting safety or assessments as judged by investigator
- Vaccination or hypersensitivity within 4 weeks before first dose
- History of severe infusion reactions or allergy to human or mouse proteins
- Hypersensitivity to HS-20093 ingredients
- Any condition compromising safety or study assessments per investigator opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 21 or 28 days from the first dose depending on the treatment combination
Participants receive HS-20093 in combination with other anti-cancer agents through IV infusions and oral administration to assess safety, tolerability, pharmacokinetics, and efficacy.
Multiple visits for dosing and assessments during this period
Duration - Up to 24 months
Participants are followed for adverse events and clinical benefit for up to 90 days after the last dose of study drug, with ongoing assessments for progression and survival up to 24 months.
Regular visits for safety and efficacy assessments
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital Zhejiang University
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
Y
Ying Yuan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
5
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here